The US Food and Drug Administration (FDA) has taken action to protect consumers against pure, powdered caffeine. The FDA’s action comes amid the agency’s wider examination of overall caffeine intake among American consumers. The warning is consistent with the distinction the FDA continues to draw – explicitly and implicitly – between caffeine as an isolated additive and caffeine as a natural component of coffee.
In formal warning letters to five distributors of pure, powdered caffeine, the FDA highlighted its concerns about package volume and misleading dosage instructions. Pure, powdered caffeine delivers extremely high doses within very small amounts. For comparison, one teaspoon is equivalent to the naturally occurring caffeine in about 28 cups of coffee. So, even small packages of pure, powdered caffeine can contain volumes well above potentially harmful or even lethal levels.
In one FDA warning letter, the agency cites package size – containing 2000 “recommended servings” or 400,000 milligrams (mg) of caffeine – as well as misleading dosage instructions. While it cites 200mg as the recommended dose, it specifies that that a quarter of a teaspoon contains 574mg. The FDA’s view is that consumers could interpret the label to mean that a quarter of a teaspoon is the intended ‘recommended serving.’
The National Coffee Association (NCA) in the US said that in all five letters the FDA’s conclusion is that the pure, powdered caffeine is ‘adulterated’ within the meaning of the Food, Drug and Cosmetic Act because it is a dietary supplement that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labelling.
Within the larger frame of the FDA’s examination of caffeine in the American diet, powdered caffeine is among unusual sources the agency appears to distinguish from naturally occurring caffeine in coffee, tea, sodas and chocolate. Other unanticipated sources of caffeine have included chewing gum (which was pulled from the market by the manufacturer), energy drinks, maple syrup and caramel popcorn.
In contrast, said the NCA, coffee has a long history of safe consumption, and its caffeine content is well known and understood by consumers. Typically, they instinctively stop drinking once they feel certain effects, with which they’re individually familiar.
The NCA has been following the FDA’s caffeine inquiry, which continues to appear consistent with comments at a kick-off public meeting by FDA Commissioner Margaret Hamburg MD, that the effort is not about coffee, which is also reflected in the meeting’s report. Since attending that meeting, the NCA has followed the FDA’s caffeine review closely, submitted a technical white paper on coffee and caffeine, and met individually with FDA officials in Washington.
